An interventional study of Circadian Lighting regimen in Anorexia Nervosa and Eating Disorder, sponsored by Mental Health Services in the Capital Region, Denmark. Terminated at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Mental Health Services in the Capital Region, Denmark · Not applicable, Interventional, and Treatment
The primary objective of this pilot study is to explore the effect of artificial lighting on affective symptoms, and the secondary aim is to explore the effect of artificial lighting on core symptoms of eating disorders (ED).
Several lines of evidence, albeit from hypothesis generation studies, suggest that artificial lighting may have a positive effect on well-being, mental health and affective symptoms in ED. The rationale of this study is to investigate the effects of artificial lighting on affective symptoms and cores symptoms of ED in inpatients undergoing weight restoration/treatment for ED.
Study design: Single-blind, controlled, pilot intervention study with circadian light (CL) comparing two CL regimens effects on mood symptoms.
Planned number of subjects: 16 patients with a ICD-10 diagnosis of Anorexia Nervosa, that completes exposure to at least three weeks of the two different CL regimens (L1 and L2) in any order.
The primary objective of this pilot study is to explore the effect of artificial lighting on affective symptoms, and the secondary aim is to explore the effect of artificial lighting on core symptoms of eating disorders (ED).
If an effect is indicated, the study will provide information on how to improve light exposure to ED patients in psychiatric treatment units. In addition, the outcomes may help identify a better system for measurement and adjustment of the specific light variables of colour temperature and light intensity.
Several lines of evidence, albeit from hypothesis generation studies, suggest that artificial lighting may have a positive effect on well-being, mental health and affective symptoms in ED. This is the rationale to investigate the effects of artificial lighting on affective symptoms and cores symptoms of ED in inpatients undergoing weight restoration/treatment for ED.
Study design: Single-blind, controlled, pilot intervention study with circadian light (CL) comparing two CL regimens effects on mood symptoms.
Planned number of subjects: 16 patients with a International Classification of Disorders 10 (ICD-10) diagnosis of Anorexia Nervosa, that completes exposure to at least three weeks of the two different CL regimens (L1 and L2) in any order.
Location: Mental Health Center Ballerup, department 14 (currently Department 5).
Diagnostic inventory: Eating Disorder Examination-Questionnaire (EDE-Q)
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's enrollment of 22 is below the median of 41 across 287 interventional studies indexed under Anorexia.
Browse Anorexia studies →Mental Health Services in the Capital Region, Denmark is the lead sponsor of 51 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
regimen L1 has overall higher intensity, higher color temperature and less light fluctuations
Other: Circadian Lighting regimen
regimen L2 has lower intensity, lower color temperature and more light fluctuations.
Other: Circadian Lighting regimen
Circadian lighting regimen with one major fluctuation, high light intensity and color
3 week change in total score of Major Depression Inventory
depression scoring, change in total score over three weeks. range 0-50. Higher values means more depressed. Mild depression: MDI total score from 21 to 25. Moderate depression: MDI total score from 26 to 30. Severe depression: MDI total score of 31 or higher.
Time frame: 3 weeks change from baseline
3 week change in total score of Eating Disorder Inventory 2
Eating disorder symptoms total score change over 3 weeks. range 0-273. Higher score means more Eating disorder symptoms.
Time frame: 3 weeks change from baseline
3 week change in video images based measure of Physical activity
video images based measure of quantity of physical activity
Time frame: 3 weeks change in physical activity from baseline
3 week change in BMI
change in Body Mass index
Time frame: 3 week change as a measure of weight change
3 week change in Visual analogue scale of mood
self assessed measure of mood symptoms, range 1-10. Higher score means more symptoms and feeling worse.
Time frame: 3 weeks change from baseline
3 week change in melatonin levels
urinary levels of melatonin
Time frame: 3 weeks change from baseline
3 week change in serotonin levels
Blood levels of serotonin
Time frame: 3 weeks change from baseline
3 week change in cortisol levels
Urinary levels of cortisol as a measure of stress
Time frame: 3 weeks change from baseline
Plan to share: Yes — All patient data
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Mental Health Services in the Capital Region, Denmark